Biologics

Emergent Details New Quality Enhancement Plan

Emergent Biosolutions says it is establishing a quality enhancement plan for its troubled Bayview manufacturing facility in Baltimore, MD. A just-released 4/30 submission to FDA was the company’s initial response to an FDA-483 that detailed nine concerns at the facility. The agency inspection followed reports of cross-contamination between Johnson & Johnson and AstraZeneca Covid-19 vaccines.

Emergent says it “knows that it must do everything within its power to ensure appropriate controls are in place to assure product quality.” It says its new plan will (1) implement enhanced contamination controls at the Bayview facility before starting new production; (2) institute effective interim controls, including Emergent corporate quality, J&J, and independent third-party oversight and monitoring; and (3) guide the development and execution of continuous improvement initiatives.

“Emergent believes that the implementation of the activities described below fully addresses the 483 observations and ensures that adequate controls are in place to support resumption of manufacturing at the Bayview facility and authorization of the Bayview facility to manufacture drug substance for the Janssen Covid-19 vaccine under the existing Janssen emergency use authorization,” the response says.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome